§ 239 — General Provisions

(a) For purposes of this part: (1) The term “covered countermeasure” means a covered countermeasure as specified in a Declaration made pursuant to section 233(p) of this title. (2) The term “covered individual” means an individual— (A) ; (B) who is or will be functioning in a role identified in a State, local, or Department of Health and Human Services smallpox emergency response plan (as defined in paragraph (7)) approved by the Secretary; (C) who has volunteered and been selected to be a member of a smallpox emergency response plan described in subparagraph (B) prior to the time at which the Secretary publicly announces that an active case of smallpox has been identified either within or outside of the United States; and (D) to whom a smallpox vaccine is administered pursuant to such approved plan during the effective period of the Declaration (including the portion of such period before April 30, 2003). (3) The term “covered injury” means an injury, disability, illness, condition, or death (other than a minor injury such as minor scarring or minor local reaction) determined, pursuant to the procedures established under section 239a of this title, to have been sustained by an individual as the direct result of— (A) administration to the individual of a covered countermeasure during the effective period of the Declaration; or (B) accidental vaccinia inoculation of the individual in circumstances in which— (i) the vaccinia is contracted during the effective period of the Declaration or within 30 days after the end of such period; (ii) smallpox vaccine has not been administered to the individual; and (iii) the individual has been in contact with an individual who is (or who was accidentally inoculated by) a covered individual. (4) The term “Declaration” means the Declaration Regarding Administration of Smallpox Countermeasures issued by the Secretary on January 24, 2003, and published in the Federal Register on January 28, 2003. (5) The term “effective period of the Declaration” means the effective period specified in the Declaration, unless extended by the Secretary. (6) The term “eligible individual” means an individual who is (as determined in accordance with section 239a of this title)— (A) a covered individual who sustains a covered injury in the manner described in paragraph (3)(A); or (B) an individual who sustains a covered injury in the manner described in paragraph (3)(B). (7) The term “smallpox emergency response plan” or “plan” means a response plan detailing actions to be taken in preparation for a possible smallpox-related emergency during the period prior to the identification of an active case of smallpox either within or outside the United States. (b) The Secretary shall ensure that a State, local, or Department of Health and Human Services plan to vaccinate individuals that is approved by the Secretary establishes procedures to ensure, consistent with the Declaration and any applicable guidelines of the Centers for Disease Control and Prevention, that— (1) potential participants are educated with respect to contraindications, the voluntary nature of the program, and the availability of potential benefits and compensation under this part; (2) there is voluntary screening provided to potential participants that can identify health conditions relevant to contraindications; and (3) there is appropriate post-inoculation medical surveillance that includes an evaluation of adverse health effects that may reasonably appear to be due to such vaccine and prompt referral of, or the provision of appropriate information to, any individual requiring health care as a result of such adverse health event.